Search Images Maps Play YouTube News Gmail Drive More »
Sign in
Screen reader users: click this link for accessible mode. Accessible mode has the same essential features but works better with your reader.

Patents

  1. Advanced Patent Search
Publication numberUS6179803 B1
Publication typeGrant
Application numberUS 09/085,741
Publication dateJan 30, 2001
Filing dateMay 28, 1998
Priority dateMay 9, 1994
Fee statusPaid
Also published asCA2299362A1, CN1272776A, DE69828617D1, DE69828617T2, EP1001710A1, EP1001710B1, US5843021, US6210355, US6416491, WO1999007299A1
Publication number085741, 09085741, US 6179803 B1, US 6179803B1, US-B1-6179803, US6179803 B1, US6179803B1
InventorsStuart D. Edwards, Ronald G. Lax
Original AssigneeSomnus Medical Technologies, Inc.
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Cell necrosis apparatus
US 6179803 B1
Abstract
An apparatus that reduces a volume of a selected site in an interior of the tongue includes a handpiece means and an electrode means at least partially positioned in the interior of the handpiece means. The electrode means includes an electrode means electromagnetic energy delivery surface and is advance able from the interior of the handpiece means into the interior of the tongue. An electrode means advancement member is coupled to the electrode means and configured to advance the electrode means an advancement distance in the interior of the tongue. The advancement distance is sufficient for the electrode means electromagnetic energy delivery surface to deliver electromagnetic energy to the selected tissue site and reduce a volume of the selected site without damaging a hypoglossal nerve. A cable means is coupled to the electrode means.
Images(16)
Previous page
Next page
Claims(63)
What is claimed is:
1. A cell necrosis apparatus to reduce a volume of a selected site in an interior of a tongue in an oral cavity, comprising:
a handpiece means;
an electrode means coupled to a distal portion of the handpiece means including a dista end insetable into tissue, the electrode means being configured to be maneuverable in the oral cavity and inserted into a tongue surface to create cell necrosis without damaging a main branch of the hypoglossal nerve, the electrode means including at least one energy delivery device with a tissue penetrating distal end that extends in the oral cavity as the electrode means is introduced into the oral cavity; and
a cable means coupled to the electrode means.
2. The apparatus of claim 1, wherein the electrode means is an RF electrode means.
3. The apparatus of claim 2, further comprising:
an RF energy source coupled to the RF electrode means.
4. The apparatus of claim 1, further comprising:
a cooling device means coupled to the electrode means.
5. The apparatus of claim 4, further comprising:
a flow rate control device means coupled to the cooling device means and configured to control a cooling medium flow rate through the cooling device means.
6. The apparatus of claim 1, further comprising:
an insulator means at least partially positioned around an exterior of the electrode means.
7. The apparatus of claim 6, further comprising:
a sensor means coupled to the electrode means.
8. The apparatus of claim 1, further comprising:
a sensor means positioned at a distal end of the electrode means.
9. The apparatus of claim 1, further comprising:
a feedback control device means coupled to the electrode means, a sensor means and an RF energy source means.
10. The apparatus of claim 1, further comprising:
an infusion medium source means coupled to the electrode means.
11. The apparatus of claim 1, wherein the electrode means has an electrode means advancement length extending from an exterior of the handpiece means to the interior of the tongue, wherein the advancement length is sufficient to position the energy delivery surface at the selected site and deliver sufficient electromagnetic energy to create cell necrosis without damaging a main branch of a hypoglossal nerve.
12. A cell necrosis apparatus to reduce a volume of a selected site in an interior of a uvula, comprising:
a handpiece means;
an electrode means coupled to a distal portion of the handpiece means including a distal end insertable into tissue, the electrode means being configured to be maneuverable in the oral cavity and inserted into a uvula surface to create cell necrosis and a repositioning of the uvula in the oral cavity while substantially preserving an uvula mucosal layer at an exterior of the uvula, the electrode means including at least one energy delivery device with a tissue penetrating distal end that extends in the oral cavity as the electrode means is introduced into the oral cavity; and
a cable means coupled to the electrode means.
13. The apparatus of claim 12, wherein the electrode means is configured to create controlled cell necrosis and the repositioning of the uvula without creating an ulceration line at a tip of the uvula.
14. The apparatus of claim 12, wherein the electrode means is configured to create controlled cell necrosis and a tightening of a uvula tissue to reposition the uvula.
15. The apparatus of claim 12, wherein the electrode means is configured to create controlled cell necrosis and a reshaping of a uvula tissue to reposition the uvula.
16. The apparatus of claim 12, wherein the electrode means is an RF electrode means.
17. The apparatus of claim 13, further comprising:
an RF energy source means coupled to the RF electrode means.
18. The apparatus of claim 12, further comprising:
a cooling device means coupled to the electrode means.
19. The apparatus of claim 18, further comprising:
a flow rate control device means coupled to the cooling device means and configured to control a cooling medium flow rate through the cooling device means.
20. The apparatus of claim 12, further comprising:
an insulator means at least partially positioned around an exterior of the electrode means.
21. The apparatus of claim 12, further comprising:
a sensor means coupled to the electrode means.
22. The apparatus of claim 12, further comprising:
a sensor means positioned at a distal end of the electrode means.
23. The apparatus of claim 12, further comprising:
a feedback control device means coupled to the electrode means, a sensor means and an RF energy source means.
24. The apparatus of claim 12, further comprising:
an infusion medium source means coupled to the electrode means.
25. The apparatus of claim 12, wherein the electrode means has an electrode means advancement length extending from an exterior of the handpiece means to the interior of the uvula, wherein the advancement length is sufficient to position the energy delivery surface at the selected site and deliver sufficient electromagnetic energy to create cell necrosis with reduced necrosis of an exterior mucosal surface.
26. A cell necrosis apparatus to reduce a volume of a selected site in an interior of a turbinate structure, comprising:
a handpiece means;
an electrode means coupled to a distal portion of the handpiece means including a distal and insertable into tissue, the electrode means being configured to be maneuverable in a nostril and inserted into a turbinate structure exterior surface, deliver electromagnetic energy to the tissue site and create cell necrosis of the turbinate structure to increase a size of a nasal passageway without sufficiently limiting blood flow to the optic nerve and create a permanent impairment of vision, the electrode means including at least one energy delivery device with a tissue penetrating distal end that extends in the oral cavity as the electrode mean is introduced into the nasal passageway; and
a cable means coupled to the electrode means.
27. The apparatus of claim 26, wherein the electrode means is adapted to create controlled cell necrosis without creating a permanent dysosmic state.
28. The apparatus of claim 26, wherein the electrode means is adapted to create controlled cell necrosis of the mucosal layer without creating a permanent dry nose condition.
29. The apparatus of claim 26, wherein the electrode means is adapted to create controlled cell necrosis of the mucosal layer without creating a permanent atrophic rhinitis condition.
30. The apparatus of claim 26, wherein the electrodes means is adapted to create controlled cell necrosis of the mucosal layer without creating a permanent loss of ciliary function.
31. The apparatus of claim 26, wherein the electrode means is an RF electrode means.
32. The apparatus of claim 30, further comprising:
an RF energy source means coupled to the RF electrode means.
33. The apparatus of claim 26, further comprising:
a cooling device means coupled to the electrode means.
34. The apparatus of claim 26, further comprising:
a flow rate control device means coupled to the cooling device means and configured to control a cooling medium flow rate through the cooling device means.
35. The apparatus of claim 26, further comprising:
an insulator means at least partially positioned around an exterior of the electrode means.
36. The apparatus of claim 26, further comprising:
a sensor means coupled to the electrode means.
37. The apparatus of claim 26, further comprising:
a sensor means positioned at a distal end of the electrode means.
38. The apparatus of claim 26, further comprising:
a feedback control device means coupled to the electrode means, a sensor means and an RF energy source means.
39. The apparatus of claim 26, further comprising:
an infusion medium source means coupled to the electrode means.
40. The apparatus of claim 26, wherein the electrode means has an electrode means advancement length extending from an exterior of the handpiece means to the interior of the turbinate structure, wherein the advancement length is sufficient to position the energy delivery surface at the selected site and deliver sufficient electromagnetic energy to the selected tissue site and create controlled cell necrosis of a mucosal layer of a turbinate bone while preserving a sufficient amount of turbinate bone and prevent creating a permanent dry nose condition.
41. A cell necrosis apparatus to reduce a volume of a selected site in an interior of a soft palate structure, comprising:
a handpiece means;
an electrode means coupled to a distal portion of the handpiece means including a distal end insertable into tissue, the electrode means being configured to be maneuverable in an oral cavity and inserted into a soft palate structure surface, deliver electromagnetic energy to the tissue site and create cell necrosis and reposition the soft palate structure in an oral cavity with reduced necrosis of an exterior mucosal surface of the soft palate structure, the electrode means including at least one energy delivery device with a tissue penetrating distal end that extends in the oral cavity as the electrode means is introduced into the oral cavity; and
a cable means coupled to the electrode means.
42. The apparatus of claim 41, wherein the electrode means is configured to create controlled cell necrosis and a tightening of a soft palate tissue to reposition the soft palate structure.
43. The apparatus of claim 41, wherein the electrode means is configured to create controlled cell necrosis and a reshaping of a soft palate tissue to reposition the soft palate structure.
44. The apparatus of claim 41, wherein the electrode means is an RF electrode means.
45. The apparatus of claim 44, further comprising:
an RF energy source means coupled to the RF electrode means.
46. The apparatus of claim 41, further comprising:
a cooling device means coupled to the electrode means.
47. The apparatus of claim 46, further comprising:
a flow rate control device means coupled to the cooling device means and configured to control a cooling medium flow rate through the cooling device means.
48. The apparatus of claim 41, further comprising:
an insulator means at least partially positioned around an exterior of the electrode means.
49. The apparatus of claim 41, further comprising:
a sensor means coupled to the electrode means.
50. The apparatus of claim 41, further comprising:
a sensor means positioned at a distal end of the electrode means.
51. The apparatus of claim 41, further comprising:
a feedback control device means coupled to the electrode means, a sensor means and an RF energy source means.
52. The apparatus of claim 41, further comprising:
an infusion medium source means coupled to the electrode means.
53. The apparatus of claim 41, wherein the electrode means has an electrode means advancement length extending from an exterior of the handpiece means to the interior of the soft palate structure, wherein the advancement length is sufficient to position the energy delivery surface at the selected site and deliver sufficient electromagnetic energy to create cell necrosis with reduced necrosis of an exterior mucosal surface of the soft palate structure.
54. A cell necrosis apparatus to reduce a volume of a selected site in an interior of a turbinate structure, comprising:
a handpiece means;
an electrode means coupled to a distal portion of the handpiece means including a distal end insertable into tissue, the electrode means being configured to be maneuverable in a nostril and inserted into a turbinate structure exterior surface, deliver electromagnetic energy to the tissue site and create cell necrosis of the turbinate structure to increase a size of a nasal passageway without sufficiently limiting blood flow to the retina and create a permanent impairment of vision, the electrode means including at least one energy delivery device with a tissue penetrating distal end that extends in the oral cavity as the electrode means is introduced into the nostril; and
a cable means coupled to the electrode means.
55. The apparatus of claim 54, wherein the electrode means is adapted to create controlled cell necrosis without creating a permanent dysosmic state.
56. The apparatus of claim 54, wherein the electrode means is adapted to create controlled cell necrosis of the mucosal layer without creating a permanent dry nose condition.
57. The apparatus of claim 54, wherein the electrode means is adapted to create controlled cell necrosis of the mucosal layer without creating a permanent atrophic rhinitis condition.
58. The apparatus of claim 54, wherein the electrodes means is adapted to create controlled cell necrosis of the mucosal layer without creating a permanent loss of ciliary function.
59. The apparatus of claim 54, wherein the electrode means is an RF electrode means.
60. The apparatus of claim 59, further comprising:
an RF energy source means coupled to the RF electrode means.
61. The apparatus of claim 54, further comprising:
a cooling device means coupled to the electrode means.
62. The apparatus of claim 54, further comprising:
an insulator means at least partially positioned around an exterior of the electrode means.
63. The apparatus of claim 54, further comprising:
a sensor means coupled to the electrode means.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No. 08/905,991, now U.S. Pat. No. 5,843,021, filed Aug. 5, 1997, entitled “Cell Necrosis Apparatus” which is a continuation-in-part of U.S. patent application Ser. No. 08/642,327, filed May 3, 1996, entitled “Method for Treatment of Airway Obstructions”, now U.S. Pat. No. 5,807,308, which application is a continuation-in-part application of U.S. patent application Ser. No. 08,606,195, filed Feb. 23, 1996, now U.S. Pat. No. 5,707,349, entitled “Method for Treatment of Airway Obstructions”, which cross-references U.S. Pat. No. 5,674,191, entitled “Ablation Apparatus and System for Removal of Soft Palate Tissue”, having named inventors Stuart D. Edwards, Edward J. Gough and David L. Douglass, which is a continuation-in-part of U.S. patent application Ser. No. 08/239,658, filed May 9, 1994, now U.S. Pat. No. 5,456,662 entitled “Method for Reducing Snoring by RF Ablation of the Uvula.” This application is also related to U.S. Pat. No. 5,728,094, entitled “Method and Apparatus for Treatment of Air Way Obstructions”, all incorporated by reference herein.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to an apparatus for the treatment of air way obstructions, and more particularly to an apparatus for creating selective cell necrosis in interior sections of selected head and neck structures without damaging vital structures.

2. Description of Related Art

Sleep-apnea syndrome is a medical condition characterized by daytime hypersomnomulence, morning arm aches, intellectual deterioration, cardiac arrhythmias, snoring and thrashing during sleep. It is caused by frequent episodes of apnea during the patient's sleep. The syndrome is classically subdivided into two types. One type, termed “central sleep apnea syndrome”, is characterized by repeated loss of respiratory effort. The second type, termed obstructive sleep apnea syndrome, is characterized by repeated apneic episodes during sleep resulting from obstruction of the patient's upper airway or that portion of the patient's respiratory tract which is cephalad to, and does not include, the larynx.

Treatment thus far includes various medical, surgical and physical measures. Medical measures include the use of medications such as protriptyline, medroxyprogesterone, acetazolamide, theophylline, nicotine and other medications in addition to avoidance of central nervous system depressants such as sedatives or alcohol. The medical measures above are sometimes helpful but are rarely completely effective. Further, the medications frequently have undesirable side effects.

Surgical interventions have included uvulopalatopharyngoplasty, tonsillectomy, surgery to correct severe retrognathia and tracheostomy. In one type of surgical intervention a standard LeFort I osteotomy is combined with a sagittal split ramus osteotomy to advance the maxilla, mandible and chin. Such a procedure may be effective but the risk of surgery in these patients can be prohibitive and the procedures are often unacceptable to the patients.

Physical measures have included weight loss, nasopharyngeal airways, nasal CPAP and various tongue retaining devices used nocturnally. These measures may be partially effective but are cumbersome, uncomfortable and patients often will not continue to use these for prolonged periods of time. Weight loss may be effective but is rarely achieved by these patients.

In patients with central sleep apnea syndrome, phrenic nerve or diaphragmatic pacing has been used. Phrenic nerve or diaphragmatic pacing includes the use of electrical stimulation to regulate and control the patient's diaphragm which is innervated bilaterally by the phrenic nerves to assist or support ventilation. This pacing is disclosed in Direct Diaphragm Stimulation by J. Mugica et al. PACE vol. 10 January-February 1987, Part II, Preliminary Test of a Muscular Diaphragm Pacing System on Human Patients by J. Mugica et al. from Neurostimulation: An Overview 1985 pp. 263-279 and Electrical Activation of Respiration by Nochomovitez IEEE Eng. in Medicine and Biology; June, 1993.

However, it was found that many of these patients also have some degree of obstructive sleep apnea which worsens when the inspiratory force is augmented by the pacer. The ventilation induced by the activation of the diaphragm also collapses the upper airway upon inspiration and draws the patient's tongue inferiorly down the throat choking the patient. These patients then require tracheostomies for adequate treatment.

A physiological laryngeal pacemaker as described in Physiological Laryngeal Pacemaker by F. Kaneko et al. from Trans Am Soc Artif Intern Organs 1985 senses volume displaced by the lungs and stimulates the appropriate nerve to open the patient's glottis to treat dyspnea. This apparatus is not effective for treatment of sleep apnea. The apparatus produces a signal proportional in the displaced air volume of the lungs and thereby the signal produced is too late to be used as an indicator for the treatment of sleep apnea. There is often no displaced air volume in sleep apnea due to obstruction.

One measure that is effective in obstructive sleep apnea is tracheostomy. However, this surgical intervention carries considerable morbidity and is aesthetically unacceptable to many patients. Other surgical procedures include a standard Le Fort I osteotomy in combination with a sagittal split ramus osteotomy. This is a major surgical intervention that requires the advancement of the maxilla, mandible and chin.

Generally, there are two types of snoring. They are distinguished, depending on the localization of their origin. The first type of snoring, velar, is produced by the vibration of all of the structures of the soft palate including the velum, the interior and posterior arches of the tonsils and the uvula. Velar snoring results from a vibration of the soft palate created by the inspiratory flow of air, both nasal and oral, which makes the soft palate wave like a flag. The sound intensity of these vibrations is accentuated by the opening of the buccal cavity which acts as a sound box.

The second type, pharyngeal snoring, is a kind of rattle, including even horn whistling. It is caused by the partial obstruction of the oropharyngeal isthmus by the base of the tongue with, now and again, its total exclusion by the tongue base becoming jammed against the posterior wall of the pharynx. This results in a sensation of breathing, apnea, which constitutes the sleep apnea syndrome. These two types of snoring may easily be combined in the same individual.

For some years there have been surgical techniques for correcting apnea. However, maxillary surgery to cure pharyngeal snoring requires major surgery, with the operation lasting several hours, and the uvula-palatopharnygoplasty procedure to correct velar snoring is not without draw backs. This explains the popularity of prosthesis and other preventive devices.

More recently, portions of the soft palate have been removed by laser ablation. If too much tissue is removed, severe consequences result. The degree of laser ablation is difficult to control and multiple treatments are usually required. Further, patients have a high degree of soreness in their throats for many weeks.

U.S. Pat. No. 4,423,812 discloses a loop electrode design characterized by a bare active wire portion suspended between wire supports on an electrode shaft. Tissue striping is effected with a bare wire, and the adjacent portions of the wire supports an electrode shaft that is made insulating to prevent accidental burns to the patient, allowing the physician to use these insulated parts to help position and guide the active wire portion during the surgical procedure. However, this requires that the physician shave off, during multiple visits, successive thin superficial layers of the obstructing tissues to avoid gross resection and its adverse affects.

U.S. Pat. No. 5,046,512 discloses a method for the treatment of snoring and apnea. The method regulates air flow to the user to an extent comparable to the volume of air which flows through the users nasal passages. An associated apparatus provides a device having a body portion sufficiently wide to separate the users teeth. It includes an air passage comparable in area to the area of the user's nasal passages.

The use of oral cavity appliances has been proposed frequently for the treatment of sleep disorders. It has been recognized that movement of the mandible forward relative to the maxilla can eliminate or reduce sleep apnea and snoring symptoms by causing the pharyngeal air passage to remain open. Several intra-oral dental appliances have been developed which the user wears at night to fix the mandible in an anterior protruded position. Such dental appliances essentially consist of acrylic or elastomeric bit blocks, similar to orthodontic retainers or athletic mouth guards, which are custom fitted to a user's upper and lower teeth. The device may be adjusted to vary the degree of anterior protrusion.

U.S. Pat. 4,901,737 discloses an intra-oral appliance while reducing snoring which repositions the mandible in an inferior, open, and anterior, protrusive, position as compared to the normally closed position of the jaw. Once the dentist or physician determines the operative snoring reduction position for a particular patient, an appropriate mold is taken for the maxillary dentition and of the mandibular dentition to form an appliance template. This device includes a pair of V-shaped spacer members formed from dental acrylic which extend between the maxillary and mandibular dentition to form a unitary mouthpiece.

While such dental appliances have proven effective in maintaining the mandible in a protruded position to improve airway patency, they often result in undesirable side effects. One of the most common side effects is aggravation of the tempromandibular joint and related jaw muscles and ligaments, especially in individuals who have a tendency to grind their teeth during sleep. Aggravation of the tempromandibular joint has be associated with a wide variety of physical ailments, including migraine headaches. Accordingly, many individuals suffering from sleep apnea and snoring disorders are not able to tolerate existing anti-snoring dental appliances for long periods of time.

Opening of obstructed nasal airways by reducing the size of the turbinates has been performed using surgical and pharmaceutical treatments. Examples of surgical procedures include anterior and posterior ethmoidectomy, such as those described in “Endoscopic Paranasal Sinus Surgery” by D. Rice and S. Schaefer, Raven Press, 1988); the writings of M. E. Wigand, Messerklinger and Stamberger; and U.S. Pat. No. 5,094,233. For example, as described in U.S. Pat. No. 5,094,233, the Wigand procedure involves the transection of the middle turbinate, beginning with the posterior aspect, visualization of the sphenoid ostium and opening of the posterior ethmoid cells for subsequent surgery. In the sphenoidectomy step, the ostium of the sphenoid is identified and the anterior wall of the sinus removed. Following this step, the posterior ethmoid cells may be entered at their junction with the sphenoid and the fovea ethmoidalis can be identified as an anatomical landmark for further dissection. In anterior ethmoidectomy, the exenteration of the ethmoids is carried anteriorly to the frontal recess. Complications, such as hemorrhage, infection, perforation of the fovea ethmoidalis or lamina papyracea, and scarring or adhesion of the middle turbinate, are reported in connection with these procedures.

One of the problems encountered as a result of these procedures is postoperative adhesion occurring between the turbinates and adjacent nasal areas, such as medial adhesion to the septum and lateral adhesion to the lateral nasal wall in the area of the ethlmoid sinuses. Otherwise successful surgical procedures may have poor results in these cases. Some surgeons have proposed amputation of a portion of the turbinate at the conclusion of surgery to avoid this complication, resulting in protracted morbidity (crust formation and nasal hygiene problems). The turbinate adhesion problem detracts from these endoscopic surgical procedures. Efforts have been made to reduce the complications associated with the surgical treatment of turbinate tissue, for example by the use of a turbinate sheath device. U.S. Pat. No. 5,094,233.

U.S. Pat. No. 3,901,241 teaches a cryosurgical instrument which is said to be useful for shrinking nasal turbinates. U.S. Pat. No. 3,901,241.

Pharmaceuticals have also been developed for reducing the size of the turbinates. However, pharmaceuticals are not always completely efficacious and generally do not provide a permanent reduction in turbinate size. In addition, pharmaceuticals can have adverse side effects.

A need exists for a method and device for clearing obstructed nasal passageways. It is preferred that the method and device be performable with minimal surgical intervention or post operative complications. It is also preferred that the method and device reduce the size of the turbinate structure without involving surgical cutting or the physical removal of tissue. It is also preferred that the method and device provide a reduction in turbinate structure size to increase air flow in the nasal passageway sufficiently impairing blood flow to the optic nerve and/or retina and create a permanent impairment of vision by the ablation.

It would be desirable to provide an ablation apparatus which eliminates the need for dental appliances for the treatment of snoring and sleep apnea disorders. It would also be desirable to provide a treatment device which is not an intra-oral dental appliance, and which can effectively and safely remove selected portions of the soft palate without providing the patient with undesirable side effects. Further, it would be desirable to provide a tissue ablation device which retains the targeted ablation tissue during the ablation process.

It would be desirable to provide an apparatus for the treatment of snoring which reduces the size of the soft palate and/or uvula with a minimal amount of cutting. It would also be desirable to provide an apparatus for the treatment snoring which is configured to position at least a portion of an energy delivery device into an interior of the soft palate and/or uvula to deliver ablation energy to the interior in order to reduce the size of the soft palate and/or uvula.

SUMMARY OF THE INVENTION

Accordingly, an object of the invention is to provide an apparatus for selective cell necrosis at selected site of different head and neck structures.

Another object of the invention is to provide an apparatus to treat airway obstructions.

Yet another object of the invention is to provide an apparatus that provides controlled cell necrosis of the tongue.

A further object of the invention is to provide an apparatus that provides controlled cell necrosis of the uvula and other soft palate structures.

Still another object of the invention is to provide an apparatus that provides controlled cell necrosis of turbinate structures.

These and other objects of the invention are achieved in a cell necrosis apparatus to reduce a volume of a selected site in an interior of a tongue in an oral cavity. The apparatus includes a handpiece means. An electrode means is coupled to a distal portion of the handpiece means and includes a distal end that is insertable into tissue. The electrode means is configured to be maneuverable in the oral cavity, inserted into a tongue surface and advance into an interior of the tongue a sufficient distance to a tissue site, deliver electromagnetic energy to the tissue site and create cell necrosis without damaging a main branch of the hypoglossal nerve. A cable means is coupled to the electrode means.

In another embodiment of the invention, a cell necrosis apparatus reduces a volume of a selected site in an interior of a uvula. The apparatus includes a handpiece means. An electrode means is coupled to a distal portion of the handpiece means and includes a distal end that is insertable into tissue. The electrode means is configured to be maneuverable in the oral cavity, be inserted into a uvula surface, advance into an interior of the uvula a sufficient distance to a tissue site, deliver electromagnetic energy to the tissue site, create controlled cell necrosis and reposition the uvula in an oral cavity with reduced necrosis of an exterior mucosal surface of the uvula. A cable means is coupled to the electrode means.

In another embodiment of the invention, a cell necrosis apparatus to reduce a volume of a selected site in an interior of a turbinate structure. The apparatus includes a handpiece means. An electrode means is coupled to a distal portion of the handpiece means including a distal end that is insertable into tissue. The electrode means is configured to be maneuverable in a nostril, inserted into a turbinate structure surface, advance into an interior of the turbinate structure a sufficient distance to a tissue site, deliver electromagnetic energy to the tissue site, create controlled cell necrosis of the turbinate structure to increase a size of a nasal passageway. The cell necrosis apparatus delivers insufficient electromagnetic energy to impair blood flow to the optic nerve and/or retina and create a permanent impairment of vision. A cable means is coupled to the electrode means.

In another embodiment of the invention, a cell necrosis apparatus reduces a volume of a selected site in an interior of a soft palate structure. The apparatus includes a handpiece means. An electrode means is coupled to a distal portion of the handpiece means including a distal end that is insertable into tissue. The electrode means is configured to be maneuverable in an oral cavity, inserted into a soft palate structure surface, advance into an interior of the soft palate structure a sufficient distance to a tissue site, deliver electromagnetic energy to the tissue site, create controlled cell necrosis and reposition the soft palate structure in an oral cavity with reduced necrosis of an exterior mucosal surface of the soft palate structure. A cable means is coupled to the electrode means.

BRIEF DESCRIPTION OF THE FIGURES

FIGS. 1A-B illustrate lateral view of the oral cavity and the positioning of the cell necrosis apparatus of the present invention in the oral cavity.

FIG. 1C depicts a lateral view of the oral cavity illustrating the repositioning of the tongue following treatment.

FIG. 2-4 illustrate the creation of various cell necrosis zones.

FIG. 5 illustrates the introduction of boluses solution to tissue.

FIG. 6A illustrates a perspective view of the cell necrosis apparatus of the present invention coupled to an energy source.

FIG. 6B illustrates a close up cross-sectional view of a hollow electrode of the invention utilized to create a cell necrosis zone below a tissue surface.

FIG. 7 illustrates a cross-sectional view of the distal end of the electrode of FIG. 6B.

FIG. 8 illustrates a cross-sectional view of the hollow electrode with a sealing plug to control fluid flow.

FIG. 9 illustrates the creation of cell necrosis zones in the uvula and the repositioning of the uvula in the oral cavity.

FIG. 10 illustrates the creation of cell necrosis zones in the turbinates and the repositioning of the turbinates in the nasal cavity.

FIG. 11 illustrates a cross-sectional view of the arteries of the nasal cavity.

FIG. 12 depicts a cross-sectional view of the head illustrating the arteries of the nasal cavity.

FIG. 13 depicts a cross-sectional view of the head taken laterally through the nasal cavity illustrating a shrinkage of the turbinates following treatment with the cell necrosis apparatus of the present invention.

FIG. 14 depicts a close up cross-sectional view of FIG. 13.

FIG. 15 depicts a cross-sectional view of the head illustrating the creation of cell necrosis zones in the soft palate structure.

FIG. 16 depicts a cross-sectional view of the soft palate structure of FIG. 15 illustrating the repositioning of the soft palate structure following creation of the cell necrosis zones.

FIG. 17 depicts a block diagram of the feed back control system that can be used with the cell necrosis apparatus as shown in FIGS. 1A-C.

FIG. 18 depicts a block diagram of an analog amplifier, analog multiplexer and microprocessor used with the feedback control system of FIG. 17.

FIG. 19 depicts a block diagram of a current sensor and voltage sensor connected to the analog amplifier of FIG. 18.

DETAILED DESCRIPTION

Referring now to FIGS. 1A-C, a cell necrosis apparatus 10 is used to reduce a volume of a selected site in an interior of a head and neck structure, and more particularly to a structure that is associated with an airway passage. Suitable anatomical structures include but are not limited to the tongue, uvula, soft palate tissue, tonsils, adenoids, turbinate structures and the like. In FIGS. 1A-C, cell necrosis apparatus 10 is shown as including a handpiece 12 coupled to an electrode 14. Handpiece 12 can be a proximal portion of electrode 14 that is suitable configured to enable placement and removal of cell necrosis apparatus to and from a selected anatomical structure and may include, in one embodiment, a proximal portion of electrode 14 that is insulated. Handpiece 12 and electrode 14 are sized and of a suitable geometry to be maneuverable in an oral cavity 16, pierce a tongue surface 18 and advance into an interior 20 of a tongue 22 a sufficient distance 24 to a tissue site 26. Electromagnetic energy is delivered to tissue site 26 to create cell necrosis at zone 28 without damaging a main branch of the hypoglossal nerve. A cable 30 is coupled to the electrode 14. For purposes of this disclosure, the main branches of the hypoglossal nerve are those branches which if damaged create an impairment, either partial or full, of speech or swallowing capabilities. As shown in FIG. 1C, the treated structure of tongue 22 is repositioned in oral cavity 16. With this cell necrosis, the back of the tongue 22 moves in a forward direction (as indicated by the arrow) away from the air passageway. The result is an increase in the cross-sectional diameter of the air passageway.

Handpiece 12 is preferably made of an electrical and thermal insulating material. Electrode 14 can be made of a conductive material such as stainless steel. Additionally, electrode 14 can be made of a shaped memory metal, such as nickel titanium, commercially available from Raychem Corporation, Menlo Park, Calif. In one embodiment, only a distal end of electrode 14 is made of the shaped memory metal in order to effect a desired deflection.

Cell necrosis apparatus 10 can include visualization capability including but not limited to a viewing scope, an expanded eyepiece, fiber optics, video imaging, and the like.

Electrode 14 can include an insulator 32 which can be adjustable in length and in a surrounding relationship to an exterior surface of electrode 14. Insulator 32 serves as a barrier to thermal or RF energy flow. Insulator 32 can be in the form of an sleeve that may be adjustably positioned at the exterior of electrode 14. In one embodiment insulator can be made of a polyamide material and be a 0.002 inch shrink wrap. The polyamide insulating layer is semi-rigid.

Handpiece 12 can have a reduced diameter at a distal portion 34 to facilitate positioning, maneuverability, provide easier access to smaller openings and improve the visibility in the area where electrode 14 is to penetrate.

To use cell necrosis apparatus 10 in oral cavity 16, a topical and then a local anesthetic is applied to tongue 22. After a suitable period for the anesthesia to take effect, the physician may grasp the body of tongue 22 near the apex, using a gauze pad for a better grip. Tongue 22 is then drawn forward, bringing the body and the root of tongue 22 further forward for improved accessibility. Grasping handpiece 12, the physician positions a distal portion of electrode at tongue surface 18.

The position of electrode 14 in FIGS. 1A-C illustrates cell necrosis zone 28 below a mucosal surface 36 providing a protected zone 38. An insulated portion 40 of electrode 14 prevents delivery of energy to a main branch of a hypoglossal nerve and/or to mucosal surface 36.

Electrode 14 can have an angle 42 at a bend zone 44 which is lateral to a longitudinal axis of handpiece 12. Electrode 14 can be malleable to create different bend zones, depending on the anatomical structure and the insertion position of the anatomical structure. With the use of a bending fixture, not shown, the arc of angle 42 can be adjusted by the physician as needed at the time of treatment.

It will be appreciated that although the term “electrode” in the specification generally means an energy delivery device including but not limited to resistive heating, RF, microwave, ultrasound and liquid thermal jet. The preferred energy source is an RF source and electrode 14 is an RF electrode operated in either bipolar or monopolar mode with a ground pad electrode. In a monopolar mode of delivering RF energy, a single electrode 14 is used in combination with an indifferent electrode patch that is applied to the body to form the other contact and complete an electrical circuit. Bipolar operation is possible when two or more electrodes 14 are used. Multiple electrodes 14 may be used.

When the energy source is RF, an RF energy source may have multiple channels, delivering separately modulated power to each electrode 14. This reduces preferential heating that occurs when more energy is delivered to a zone of greater conductivity and less heating occurs around electrodes 14 which are placed into less conductive tissue. If the tissue hydration or blood infusion in the tissue is uniform, a single channel RF energy source may be used to provide power for the treatment and cell necrosis zones are relatively uniform in size.

One or more sensors 46 can be included and positioned at a distal end of electrode 14, at a distal end of insulator 32, as well as at other positions of cell necrosis apparatus 10. Sensor 46 is of conventional design, including but not limited to thermistors, thermocouples, resistive wires, and the like. A suitable sensor 46 is a T type thermocouple with copper constantene, J type, E type, K type, fiber optics, resistive wires, thermocouple IR detectors, and the like.

Electrode 14 can experience a steep temperature gradient as current moves outward the electrode 14. This causes the tissue that is immediately adjacent to electrode 14 to reach temperatures of 100 degrees C. or more while tissue only 5 to 10 mm away may be at or near body temperature. Because of this temperature gradient it is often necessary to place electrode 14 several times or use a plurality of electrodes 14 to create a cell necrosis zone 28 of the desired volume. Because of the aggressive heating immediately proximal of electrode 14 desiccation of tissue adjacent to electrode 14 may result. When the fluid within the tissue is desiccated, no electrical current flows through the tissue and the heating is then terminated. This problem can be solved by using a lower rate of heating which requires extended treatment periods.

Referring now to FIGS. 2 through 4, an embodiment of the invention is disclosed where electrode 14 includes a hollow lumen 48 and a plurality of apertures through which a fluid medium can flow. Suitable fluid mediums include but are not limited to cooling and heating fluids, electrolytic solutions, chemical ablation medium, a disinfectant medium and the like.

A suitable electrolytic solution is saline, solutions of calcium salts, potassium salts, and the like. Electrolytic solutions enhance the electrical conductivity of the tissue. When a highly conductive fluid is infused into tissue, the ohmic resistance is reduced and the electrical conductivity of the infused tissue is increased. With this condition there will be little tendency for tissue surrounding electrode 14 to desiccate and the result is a large increase in the capacity of the tissue to carry RF energy. A zone of tissue which has been heavily infused with a concentrated electrolytic solution can then become so conductive as to actually act as an electrode. The effect of the larger (fluid) electrode is that greater amounts of current can be conducted, making it possible to heat a much greater volume of tissue in a given time period.

In addition to the larger electrode area that results from infusion of an electrolytic solution it is then possible to inject one or more boluses 50 of electrolytic solution as shown in FIG. 5. RF current 52 can then flow through the infused tissue surrounding electrode 14 and follow the course of least electrical resistance into the infused tissue of the neighboring bolus.

By placing the injections of electrolytic solution according to the need for thermal tissue damage, a single electrode 14 may deliver heating to a large volume of tissue and the shape of cell necrosis zone 28 created may be placed to create cell necrosis in exactly the area desired. This simplifies the control of cell necrosis zone 28 generation and allows the physician to produce larger lesions in a brief session.

Additionally, the conductivity of the injected electrolytic solution can be decreased. While the advantages of avoiding desiccation adjacent to electrode 14 are maintained, higher ohmic resistance is encountered in the infused tissue. This results in greater heating in the tissue closer to electrode 14. Varying the electrical conductivity of the infused tissue can be used to adjust the size of cell necrosis zone 28 and control the extent of thermal damage.

Disinfectant mediums can also be introduced through electrode 14. Suitable disinfectant mediums include but are not limited to Peridex, an oral rinse containing 0.12% chlorhexidine glucinate (1, 1′-hexanethylenebis[5-(p-chlorophenyl)biganide} di-D-gluconate in a base containing water, 11.6% alcohol, glycerin, PEG 40 sorbitan arisoterate, flavor, dosium saccharin, and FD&C Blue No. 1. The disinfectant medium can be introduced prior to, during and after cell necrosis.

Referring now to FIGS. 6 through 8, electrode 14 may include hollow lumen 48 that is in fluid communication with a control unit 54 which controls the delivery of the fluid via a conduit 56 configured to receive a cooling or heating solution. All of only a portion of a distal portion 14′ of electrode 14 is cooled or heating.

The introduction of a cooling fluid reduces cell necrosis of surface layers without the use of insulator 32. This preserves surface mucosal and/or epidermal layers as well as protects a tissue site in the vicinity or in cell necrosis zone 28 from receiving sufficient energy to cause cell necrosis. For instance, it may be desirable to insert electrode 14 into an organ in a position which is adjacent to or even within some feature that must be preserved while treating other areas including but not limited to blood vessels, nerve bundles, glands and the like. The use of cooling permits the delivery of thermal energy in a predetermined pattern while avoiding heating critical structures.

A sealing plug 58 may be positioned in hollow electrode 14 and used to determine the length of electrode 14 that receives the cooling fluid. Sealing plug 58 can include one or more sealing wipers 60 positioned on an outer diameter of sealing plug 58. A fluid tube 62 is coupled to a proximal portion of sealing plug 58 and positioned adjacent to the proximal surface of sealing plug 58. A plurality of fluid distribution ports 64 are formed in fluid tube 62. Cooling fluid, which may be a saline solution or other biologically compatible fluid, is fed from control unit 54 through a small diameter dual lumen tube positioned in conduit 56. Cooling fluid flows through fluid tube 62 to the most distal end where it exits through fluid distribution ports 64 arranged about the outer diameter of fluid tube 62. Cooling fluid then flows within hollow lumen 48 and is in direct contact with the wall structure of electrode 14, which is typically metallic and provides a highly efficient heat transfer. Cooling fluid flows to the proximal end of electrode 14 and through the second lumen of the fluid tube 62, then to control unit 54 which includes both a supply reservoir and a return reservoir to catch and retained the used cooling fluid.

Electrode 14 may have one or more sensors 46 for sensing the temperature of the tissue. This data is fed back to control unit 54 and through an algorithm is stored within a microprocessor memory of control unit 54. Instructions are sent to an electronically controlled micropump (not shown) to deliver fluid through the fluid lines at the appropriate flow rate and duration to provide control of tissue temperature.

The reservoir of control unit 54 may have the ability to control the temperature of the cooling fluid by either cooling the fluid or heating the fluid. Alternatively, a fluid reservoir of sufficient size may be used in which the cooling fluid is introduced at a temperature at or near that of the normal body temperature. Using a thermally insulated reservoir, adequate control of the tissue temperature may be accomplished without need of refrigeration or heating of the cooling fluid.

Cooling zone 66 is adjustable in size and location by moving sealing plug 58 using a stylet 68 which is controlled by a slider 70 position at handpiece 12. In this manner, the position of cooling zone 66 can be moved along the length of electrode 14 and the area which is cooled is then proximal of sealing plug 58. In the event it is desirable to have cooling zone 66 within a length of electrode 14 then a second sealing plug 58 can be positioned at a distance proximal of the first or distal sealing plug 58 and the cooling fluid then re-enters the second lumen of fluid tube 62 at proximal sealing plug 58. The distance between the two sealing plugs 58 determines the length of cooling zone 66. In this example, the distal and proximal sealing plugs 58 move together when activated by stylet 68, re-positioning cooling zone 66.

In another embodiment, the distal and proximal sealing plugs 58 are adjusted individually. This provides the ability to both change the position and length of cooling zone 66.

In typical use, cooling zone 66 is positioned so that a predetermined thickness of mucosal or epidermal tissue 72 on the surface of the tissue to be treated 74 is protected as indicated at area 75 while the desired cell necrosis zone 28 is formed.

An alternative feature is the ability to indicate to the physician the amount of electrode 14 length that is inserted into the tissue and the depth of protected area 75. To accomplish this, a portion of cell necrosis apparatus 10 comes in contact with mucosal or epidermal tissue 72. This can be achieved with a contact collar 76 or with a larger surface that is contoured to fit against the organ or anatomical feature to be treated. The dimensional relationship between contact collar 76 and handpiece 12 is maintained by a sleeve 78 through which electrode 14, fluid tube 62 and stylet 68 all pass. With this dimensional relationship maintained, it is then possible to indicate with indexing pointers on handpiece 12 the distance of electrode 14 distal of contact collar 76 or the surface of cell necrosis apparatus 10. The distance of cooling zone 66 is then positioned distal of contact collar 76 or the surface cell necrosis apparatus 10. Because all cooling is within electrode 14 and external insulator 32 is not used, electrode 14 penetrates easily through the tissue without drag or resistance that is present when insulator 32 is present.

In another embodiment, sealing plugs 58 and direct flow of cooling fluid are replaced with a slidable inner cooling plug which may be constructed of a material with efficient heat transfer characteristics. Suitable cooling plug materials include but are not limited to copper, beryllium copper, silver and aluminum alloys. Cooling plug is sized to fit intimately against the inner surface of electrode 14. This allows transfer of heat from electrode 14 to cooling the plug. In this embodiment, cooling plug has interior passageways through which cooling fluid passes. This draws heat from the cooling plug.

Although this embodiment does not provide the highly efficient cooling available by having the cooling fluid in direct contact with the inner surface of electrode 14, a more thorough isolation of the cooling fluid from the body is provided. This results from reducing the possibility of experiencing some leakage past sealing plug 58 of the other embodiment.

In yet another embodiment of cooling, heat pipe technology is used. A sealed compartment contains a mixture of gases which have the ability to rapidly vaporize and condense at temperatures which facilitate the transfer of heat with high efficiency. In this embodiment, a cooling module within handpiece 12 cools the proximal end of the tubular heat pipe and heat is conducted from cooling zone 66 to the cooling module.

Cell necrosis apparatus 10 can be used to create cell necrosis in other structures that affect airway passages including but not limited to the uvula, turbinate structures, soft palate structures and tonsils.

As shown in FIGS. 9 and 10, cell necrosis apparatus 10 is used to create one or more cell necrosis zones 28 in uvula 80. Electrode 14 is configured to be maneuverable in oral cavity 16 , pierce an uvula exterior surface, advance into an interior of the uvula a sufficient distance to a tissue site, deliver electromagnetic energy to the tissue site and create controlled cell necrosis. The creation of cell necrosis zones 28 repositions the treated uvula 80 in oral cavity 16 (as indicated by the arrows) while substantially preserving an uvula mucosal layer 82 at an exterior of uvula 80. Cell necrosis zones 28 are created in uvula 80 without creating an ulceration line at a tip 86 of uvula 80. Controlled cell necrosis tightens and reshapes uvula 80.

In creating uvula 80, electrode 14 can have a variety of geometric configurations and may include a curved distal end. The different cell necrosis zones 28 can be stacked in one or more treatment sessions. This permits the physician to control the amount of tissue treated and to assess the results of each session before proceeding with additional procedures. Because exterior mucosal tissue is spared, the patient experiences little pain or discomfort.

Referring now to FIG. 10, cell necrosis apparatus 10 is used to create cell necrosis zones 28 in a turbinate structure 88, which can include the interior nasal concha, the middle nasal concha, the superior nasal concha, and combinations thereof. Electrode 14 is configured to be maneuverable in a nostril, pierce a turbinate structure surface 88 advance into an interior of turbinate structure 88 a sufficient distance to a tissue site, deliver electromagnetic energy to the tissue site and create controlled cell necrosis of turbinate structure 88 to increase a size of a nasal passageway 90.

Sufficient electromagnetic energy is delivered to the tissue site to create controlled cell necrosis of the turbinate structure without sufficiently limiting blood flow to the optic nerve and/or the retina (FIG. 11). As shown in FIG. 12 disruption of the blood flow to the optic nerve and/or retina can sufficiently damage the optic nerve and/or retina and create a permanent impairment of vision.

Referring again to FIG. 10, electrode 14 creates cell necrosis zones 28 to reduce the size turbinate structure 88 by removing only so much of turbinate structure 88 to increase the size of the nasal passageway but insufficient to create a permanent, (i) dysosmic state, (ii) dry nose condition, (iii) atrophic rhinitis state, (iv) a loss of ciliary function or (v) damage to the nerves of nasal cavity creating a permanent loss of nasal and facial structure activity. The creation of the ablation zones in turbinate structure 88 repositions turbinate structure 88. In one embodiment, no more than 33% of the mucosal layer of the lower turbinate is removed. Further removal may create the dysosmic state, a permanent dry nose condition and/or a loss of ciliary function.

As illustrated in FIGS. 13 and 14, cell necrosis apparatus 10 provides controlled ablation of turbinate structures 88 and the resulting turbinate structure is repositioned in the nasal cavity, and can “open up” the nasal cavity for allergy sufferers and the like.

In another embodiment (FIGS. 15 and 16), cell necrosis apparatus 10 reduces a volume of a selected site in an interior of a soft palate structure 94. Electrode 14 is configured to be maneuverable in oral cavity 16, pierce a soft palate structure surface 94, advance a sufficient distance to a tissue site, deliver electromagnetic energy to the tissue site, create controlled cell necrosis zones 28 and reposition soft palate structure 94 in oral cavity 16 with reduced necrosis of an exterior mucosal surface of soft palate structure 94. The creation of cell necrosis zones 28 repositions soft palate structure 94 and tightens the interior tissue of soft palate structure as illustrated by the arrows.

Again, various imaging devices and methods, well known in the art, may be used to position electrode 14 and/or determine the amount of cell necrosis.

In one embodiment, cell necrosis apparatus 10 is coupled to an open or closed loop feedback system. Referring now to FIG. 17 an open or closed loop feedback system couples sensor 46 to energy source 92. In this embodiment, electrode 14 is one or more RF electrodes 14. It will be appreciated that other energy delivery devices 14 can also be used with the feedback system.

The temperature of the tissue, or of RF electrode 14 is monitored, and the output power of energy source 92 adjusted accordingly. Additionally, the level of disinfection in the oral cavity can be monitored. The physician can, if desired, override the closed or open loop system. A microprocessor can be included and incorporated in the closed or open loop system to switch power on and off, as well as modulate the power. The closed loop system utilizes a microprocessor 194 to serve as a controller, monitor the temperature, adjust the RF power, analyze at the result, refeed the result, and then modulate the power.

With the use of sensor 46 and the feedback control system a tissue adjacent to RF electrode 14 can be maintained at a desired temperature for a selected period of time without impeding out. Each RF electrode 14 is connected to resources which generate an independent output. The output maintains a selected energy at RF electrode 14 for a selected length of time.

Current delivered through RF electrode 14 is measured by current sensor 196. Voltage is measured by voltage sensor 198. Impedance and power are then calculated at power and impedance calculation device 100. These values can then be displayed at user interface and display 102. Signals representative of power and impedance values are received by a controller 104.

A control signal is generated by controller 104 that is proportional to the difference between an actual measured value, and a desired value. The control signal is used by power circuits 106 to adjust the power output in an appropriate amount in order to maintain the desired power delivered at respective RF electrodes 14.

In a similar manner, temperatures detected at sensor 46 provide feedback for maintaining a selected power. Temperature at sensor 46 are used as safety devices to interrupt the delivery of energy when maximum pre-set temperatures are exceeded. The actual temperatures are measured at temperature measurement device 108, and the temperatures are displayed at user interface and display 102. A control signal is generated by controller 104 that is proportional to the difference between an actual measured temperature and a desired temperature. The control signal is used by power circuits 106 to adjust the power output in an appropriate amount in order to maintain the desired temperature delivered at the sensor 46. A multiplexer can be included to measure current, voltage and temperature, at the sensor 46, and energy can be delivered to RF electrode 14 in monopolar or bipolar fashion.

Controller 104 can be a digital or analog controller, or a computer with software. When controller 104 is a computer it can include a CPU coupled through a system bus. On this system can be a keyboard, a disk drive, or other non-volatile memory systems, a display, and other peripherals, as are known in the art. Also coupled to the bus is a program memory and a data memory.

User interface and display 102 includes operator controls and a display. Controller 104 can be coupled to imaging systems, including but not limited to ultrasound, CT scanners, X-ray, MRI, mammographic X-ray and the like. Further, direct visualization and tactile imaging can be utilized.

The output of current sensor 196 and voltage sensor 198 is used by controller 104 to maintain a selected power level at RF electrode 14. The amount of RF energy delivered controls the amount of power. A profile of power delivered can be incorporated in controller 104 and a preset amount of energy to be delivered may also be profiled.

Circuitry, software and feedback to controller 104 result in process control, and the maintenance of the selected power setting that is independent of changes in voltage or current, and used to change, (i) the selected power setting, (ii) the duty cycle (on-off time), (iii) bipolar or monopolar energy delivery and (iv) fluid delivery, including flow rate and pressure. These process variables are controlled and varied, while maintaining the desired delivery of power independent of changes in voltage or current, based on temperatures monitored at sensor 46.

Referring to FIG. 18, current sensor 196 and voltage sensor 198 are connected to the input of an analog amplifier 110. Analog amplifier 110 can be a conventional differential amplifier circuit for use with sensor 46. The output of analog amplifier 110 is sequentially connected by an analog multiplexer 112 to the input of A/D converter 114. The output of analog amplifier 110 is a voltage which represents the respective sensed temperatures. Digitized amplifier output voltages are supplied by A/D converter 114 to microprocessor 194. Microprocessor 194 may be a type 68HCII available from Motorola. However, it will be appreciated that any suitable microprocessor or general purpose digital or analog computer can be used to calculate impedance or temperature.

Microprocessor 194 sequentially receives and stores digital representations of impedance and temperature. Each digital value received by microprocessor 194 corresponds to different temperatures and impedances.

Calculated power and impedance values can be indicated on user interface and display 102. Alternatively, or in addition to the numerical indication of power or impedance, calculated impedance and power values can be compared by microprocessor 194 with power and impedance limits. When the values exceed predetermined power or impedance values, a warning can be given on user interface and display 102, and additionally, the delivery of RF energy can be reduced, modified or interrupted. A control signal from microprocessor 194 can modify the power level supplied by energy source 92.

FIG. 19 illustrates a block diagram of a temperature/impedance feedback system that can be used to control temperature control fluid flow rate through electrode 14. Energy is delivered to RF electrode 14 by energy source 92, and applied to tissue. A monitor 116 ascertains tissue impedance, based on the energy delivered to tissue, and compares the measured impedance value to a set value. If the measured impedance exceeds the set value a disabling signal 118 is transmitted to energy source 92, ceasing further delivery of energy to electrode 14. If measured impedance is within acceptable limits, energy continues to be applied to the tissue. During the application of energy sensor 46 measures the temperature of tissue and/or electrode 14. A comparator 120 receives a signal representative of the measured temperature and compares this value to a pre-set signal representative of the desired temperature. Comparator 120 sends a signal to a flow regulator 122 representing a need for a higher temperature control fluid flow rate, if the tissue temperature is too high, or to maintain the flow rate if the temperature has not exceeded the desired temperature.

The foregoing description of a preferred embodiment of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Obviously, many modifications and variations will be apparent to practitioners skilled in this art. It is intended that the scope of the invention be defined by the following claims and their equivalents.

Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US1798902Nov 5, 1928Mar 31, 1931Raney Edwin MSurgical instrument
US3901241May 31, 1973Aug 26, 1975Al Corp DuDisposable cryosurgical instrument
US4011872Mar 28, 1975Mar 15, 1977Olympus Optical Co., Ltd.Electrical apparatus for treating affected part in a coeloma
US4196724Jan 31, 1978Apr 8, 1980Frecker William HTongue locking device
US4411266Sep 24, 1980Oct 25, 1983Cosman Eric RThermocouple radio frequency lesion electrode
US4423812Sep 15, 1981Jan 3, 1984Olympus Optical Company LimitedCassette receptacle device
US4532924Apr 30, 1982Aug 6, 1985American Hospital Supply CorporationFor use in the treatment of tissue
US4565200May 4, 1982Jan 21, 1986Cosman Eric RUniversal lesion and recording electrode system
US4901737Apr 13, 1987Feb 20, 1990Toone Kent JMethod and therapeutic apparatus for reducing snoring
US4906203Oct 24, 1988Mar 6, 1990General Motors CorporationElectrical connector with shorting clip
US4907589Apr 29, 1988Mar 13, 1990Cosman Eric RAutomatic over-temperature control apparatus for a therapeutic heating device
US4943290Apr 27, 1989Jul 24, 1990Concept Inc.Electrolyte purging electrode tip
US4947842Feb 13, 1989Aug 14, 1990Medical Engineering And Development Institute, Inc.Method and apparatus for treating tissue with first and second modalities
US4966597Nov 4, 1988Oct 30, 1990Cosman Eric RThermometric cardiac tissue ablation electrode with ultra-sensitive temperature detection
US4976711Apr 13, 1989Dec 11, 1990Everest Medical CorporationAblation catheter with selectively deployable electrodes
US5046512Aug 30, 1989Sep 10, 1991Murchie John AMethod and apparatus for treatment of snoring
US5057107Feb 19, 1991Oct 15, 1991Everest Medical CorporationAblation catheter with selectively deployable electrodes
US5078717Sep 10, 1990Jan 7, 1992Everest Medical CorporationAblation catheter with selectively deployable electrodes
US5083565Aug 3, 1990Jan 28, 1992Everest Medical CorporationElectrosurgical instrument for ablating endocardial tissue
US5094233Jan 11, 1991Mar 10, 1992Brennan Louis GPost-operative separation; nasal septum
US5100423Aug 21, 1990Mar 31, 1992Medical Engineering & Development Institute, Inc.Ablation catheter
US5122137Apr 27, 1990Jun 16, 1992Boston Scientific CorporationTemperature controlled rf coagulation
US5125928Feb 19, 1991Jun 30, 1992Everest Medical CorporationAblation catheter with selectively deployable electrodes
US5147308Jan 4, 1990Sep 15, 1992Andrew SingerSurgical needle and stylet with a guard
US5190541Oct 17, 1990Mar 2, 1993Boston Scientific CorporationSurgical instrument and method
US5197963Dec 2, 1991Mar 30, 1993Everest Medical CorporationElectrosurgical instrument with extendable sheath for irrigation and aspiration
US5197964Nov 12, 1991Mar 30, 1993Everest Medical CorporationBipolar instrument utilizing one stationary electrode and one movable electrode
US5203866May 8, 1991Apr 20, 1993Islam Abul B M AStiletted needles
US5215103Sep 13, 1989Jun 1, 1993Desai Jawahar MCatheter for mapping and ablation and method therefor
US5256138Oct 4, 1990Oct 26, 1993The Birtcher CorporationElectrosurgical handpiece incorporating blade and conductive gas functionality
US5257451Nov 8, 1991Nov 2, 1993Ep Technologies, Inc.Method of making durable sleeve for enclosing a bendable electrode tip assembly
US5275162Nov 25, 1992Jan 4, 1994Ep Technologies, Inc.Valve mapping catheter
US5277201May 1, 1992Jan 11, 1994Vesta Medical, Inc.Endometrial ablation apparatus and method
US5281216Mar 31, 1992Jan 25, 1994Valleylab, Inc.Electrosurgical bipolar treating apparatus
US5281217Apr 13, 1992Jan 25, 1994Ep Technologies, Inc.Steerable antenna systems for cardiac ablation that minimize tissue damage and blood coagulation due to conductive heating patterns
US5281218Jun 5, 1992Jan 25, 1994Cardiac Pathways CorporationCatheter having needle electrode for radiofrequency ablation
US5290286Dec 9, 1992Mar 1, 1994Everest Medical CorporationBipolar instrument utilizing one stationary electrode and one movable electrode
US5293869Sep 25, 1992Mar 15, 1994Ep Technologies, Inc.Cardiac probe with dynamic support for maintaining constant surface contact during heart systole and diastole
US5309910Sep 25, 1992May 10, 1994Ep Technologies, Inc.Cardiac mapping and ablation systems
US5313943Sep 25, 1992May 24, 1994Ep Technologies, Inc.Catheters and methods for performing cardiac diagnosis and treatment
US5314466Apr 13, 1992May 24, 1994Ep Technologies, Inc.Articulated unidirectional microwave antenna systems for cardiac ablation
US5316020Sep 30, 1991May 31, 1994Ernest TrufferSnoring prevention device
US5328467Nov 8, 1991Jul 12, 1994Ep Technologies, Inc.Catheter having a torque transmitting sleeve
US5334196Oct 5, 1992Aug 2, 1994United States Surgical CorporationEndoscopic fastener remover
US5348554Dec 1, 1992Sep 20, 1994Cardiac Pathways CorporationCatheter for RF ablation with cooled electrode
US5363861Nov 8, 1991Nov 15, 1994Ep Technologies, Inc.Electrode tip assembly with variable resistance to bending
US5365926Oct 13, 1992Nov 22, 1994Desai Jawahar MCatheter for mapping and ablation and method therefor
US5365945Apr 13, 1993Nov 22, 1994Halstrom Leonard WAdjustable dental applicance for treatment of snoring and obstructive sleep apnea
US5366490Dec 22, 1993Nov 22, 1994Vidamed, Inc.Medical probe device and method
US5368557May 5, 1993Nov 29, 1994Baxter International Inc.Ultrasonic ablation catheter device having multiple ultrasound transmission members
US5368592Sep 23, 1993Nov 29, 1994Ep Technologies, Inc.Articulated systems for cardiac ablation
US5370675Feb 2, 1993Dec 6, 1994Vidamed, Inc.Medical probe device and method
US5370678Dec 7, 1993Dec 6, 1994Ep Technologies, Inc.Steerable microwave antenna systems for cardiac ablation that minimize tissue damage and blood coagulation due to conductive heating patterns
US5383876Mar 22, 1994Jan 24, 1995American Cardiac Ablation Co., Inc.Fluid cooled electrosurgical probe for cutting and cauterizing tissue
US5383917Jul 5, 1991Jan 24, 1995Jawahar M. DesaiDevice and method for multi-phase radio-frequency ablation
US5385544May 14, 1993Jan 31, 1995Vidamed, Inc.Medical probe device for medical treatment of the prostate
US5397339May 7, 1993Mar 14, 1995Desai; Jawahar M.Catheter for mapping and ablation and method therefor
US5398683Jul 16, 1993Mar 21, 1995Ep Technologies, Inc.Combination monophasic action potential/ablation catheter and high-performance filter system
US5401272Feb 16, 1994Mar 28, 1995Envision Surgical Systems, Inc.Multimodality probe with extendable bipolar electrodes
US5403311Mar 29, 1993Apr 4, 1995Boston Scientific CorporationElectro-coagulation and ablation and other electrotherapeutic treatments of body tissue
US5409453Aug 19, 1993Apr 25, 1995Vidamed, Inc.Steerable medical probe with stylets
US5421819May 13, 1993Jun 6, 1995Vidamed, Inc.Medical probe device
US5423808Nov 29, 1993Jun 13, 1995Ep Technologies, Inc.Systems and methods for radiofrequency ablation with phase sensitive power detection
US5423811Mar 16, 1994Jun 13, 1995Cardiac Pathways CorporationMethod for RF ablation using cooled electrode
US5423812Jan 31, 1994Jun 13, 1995Ellman; Alan G.Electrosurgical stripping electrode for palatopharynx tissue
US5433739Nov 2, 1993Jul 18, 1995Sluijter; Menno E.Method and apparatus for heating an intervertebral disc for relief of back pain
US5435805May 13, 1993Jul 25, 1995Vidamed, Inc.Medical probe device with optical viewing capability
US5441499Jul 13, 1994Aug 15, 1995Dekna Elektro-U. Medizinische Apparatebau Gesellschaft MbhBipolar radio-frequency surgical instrument
US5456662 *May 9, 1994Oct 10, 1995Edwards; Stuart D.Method for medical ablation of tissue
US5456682Feb 2, 1994Oct 10, 1995Ep Technologies, Inc.Electrode and associated systems using thermally insulated temperature sensing elements
US5458596May 6, 1994Oct 17, 1995Dorsal Orthopedic CorporationMethod and apparatus for controlled contraction of soft tissue
US5458597Nov 8, 1993Oct 17, 1995Zomed InternationalFor delivering chemotherapeutic agents in a tissue treatment site
US5470308Nov 19, 1993Nov 28, 1995Vidamed, Inc.Medical probe with biopsy stylet
US5471982Sep 29, 1992Dec 5, 1995Ep Technologies, Inc.Cardiac mapping and ablation systems
US5472441Mar 11, 1994Dec 5, 1995Zomed InternationalDevice for treating cancer and non-malignant tumors and methods
US5484400Mar 23, 1994Jan 16, 1996Vidamed, Inc.Dual channel RF delivery system
US5486161Nov 8, 1993Jan 23, 1996Zomed InternationalMedical probe device and method
US5505728Jan 9, 1995Apr 9, 1996Ellman; Alan G.Electrosurgical stripping electrode for palatopharynx tissue
US5505730Jun 24, 1994Apr 9, 1996Stuart D. EdwardsThin layer ablation apparatus
US5507743Aug 16, 1994Apr 16, 1996Zomed InternationalCoiled RF electrode treatment apparatus
US5509419Dec 16, 1993Apr 23, 1996Ep Technologies, Inc.Cardiac mapping and ablation systems
US5514130Oct 11, 1994May 7, 1996Dorsal Med InternationalRF apparatus for controlled depth ablation of soft tissue
US5514131Sep 23, 1994May 7, 1996Stuart D. EdwardsMethod for the ablation treatment of the uvula
US5520684Aug 3, 1994May 28, 1996Imran; Mir A.Transurethral radio frequency apparatus for ablation of the prostate gland and method
US5531676Sep 27, 1994Jul 2, 1996Vidamed, Inc.For treatment of a prostate
US5531677Apr 11, 1995Jul 2, 1996Vidamed, Inc.Steerable medical probe with stylets
US5536240Sep 27, 1994Jul 16, 1996Vidamed, Inc.For the treatment of benign prostatic hypertrophy of the prostate
US5536267Aug 12, 1994Jul 16, 1996Zomed InternationalMultiple electrode ablation apparatus
US5540655Jan 5, 1995Jul 30, 1996Vidamed, Inc.For treatment by radio frequency of a target tissue mass of a prostate
US5542916Sep 28, 1994Aug 6, 1996Vidamed, Inc.Dual-channel RF power delivery system
US5545161Oct 7, 1994Aug 13, 1996Cardiac Pathways CorporationCatheter for RF ablation having cooled electrode with electrically insulated sleeve
US5545171Sep 22, 1994Aug 13, 1996Vidamed, Inc.Medical probe device
US5545193Aug 22, 1995Aug 13, 1996Ep Technologies, Inc.Helically wound radio-frequency emitting electrodes for creating lesions in body tissue
US5545434Nov 8, 1994Aug 13, 1996Huarng; HermesMethod of making irregularly porous cloth
US5549108Jun 1, 1994Aug 27, 1996Ep Technologies, Inc.Cardiac mapping and ablation systems
US5549644Feb 2, 1994Aug 27, 1996Vidamed, Inc.Transurethral needle ablation device with cystoscope and method for treatment of the prostate
US5554110Jan 12, 1994Sep 10, 1996Vidamed, Inc.Medical ablation apparatus
US5556377Dec 22, 1993Sep 17, 1996Vidamed, Inc.Medical probe apparatus with laser and/or microwave monolithic integrated circuit probe
US5558672Aug 4, 1994Sep 24, 1996Vidacare, Inc.Thin layer ablation apparatus
US5558673Sep 30, 1994Sep 24, 1996Vidamed, Inc.Medical probe device and method having a flexible resilient tape stylet
US5599345Aug 24, 1994Feb 4, 1997Zomed International, Inc.RF treatment apparatus
US5674191 *Aug 18, 1995Oct 7, 1997Somnus Medical Technologies, Inc.Ablation apparatus and system for removal of soft palate tissue
US5728094 *May 3, 1996Mar 17, 1998Somnus Medical Technologies, Inc.Method and apparatus for treatment of air way obstructions
US5743904 *Jun 7, 1996Apr 28, 1998Somnus Medical Technologies, Inc.Precision placement of ablation apparatus
US5800379 *Aug 12, 1996Sep 1, 1998Sommus Medical Technologies, Inc.Method for ablating interior sections of the tongue
US5807308 *May 3, 1996Sep 15, 1998Somnus Medical Technologies, Inc.Method and apparatus for treatment of air way obstructions
US5843021 *Aug 5, 1997Dec 1, 1998Somnus Medical Technologies, Inc.Cell necrosis apparatus
Non-Patent Citations
Reference
1Kaneko, et al., Physiological Laryngeal Pacemaker, May 1985, Trans Am Soc Artif Intern Organs, vol. XXXI, pp. 293-296.
2Mugica, et al., Direct Diaphragm Stimulation, Jan., 1987, PACE, vol. 10, pp. 252-256.
3Mugica, et al., Neurostimulation: An Overview, Chapter 21, Premliminary Test of a Muscular Diaphragm Pacing System on Human Patients, 1985, pp. 263-279.
4Nochomovitz, et al., Electrical Activation of the Diaphragm, Jun. 1988, Clinics in Chest Medicine, vol. 9, No. 2, pp. 349-358.
5Prior, et al., Treatment of Menorrhagia by Radiofrequency Heating, 1991, Int. J. Hyperthermia, vol. 7, pp. 213-220.
6Rice, et al., Endoscopic Paranasal Sinus Surgery, Chapter 5, Functional Endoscopic Paranasal Sinus Surgery, The Technique of Messerklinger, Raven Press, 1988, pp. 75-104.
7Rice, et al., Endoscopic Paranasal Sinus Surgery, Chapter 6, Total Endoscopic Sphenoethmoidectomy, The Technique of Wigand, Raven Press, 1988, pp. 105-125.
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US6425883Aug 11, 1999Jul 30, 2002Circuit Tree Medical, Inc.Method and apparatus for controlling vacuum as a function of ultrasonic power in an ophthalmic phaco aspirator
US6478781Apr 11, 2000Nov 12, 2002Circuit Tree Medical, Inc.Anterior chamber stabilizing device for use in eye surgery
US6682501 *Jun 10, 1999Jan 27, 2004Gyrus Ent, L.L.C.Submucosal tonsillectomy apparatus and method
US7537594 *Apr 27, 2004May 26, 2009Covidien AgSuction coagulator with dissecting probe
US8286339 *Feb 18, 2009Oct 16, 2012Tyco Healthcare Group LpTwo piece tube for suction coagulator
US8328804Jul 24, 2008Dec 11, 2012Covidien LpSuction coagulator
US8702697Apr 12, 2012Apr 22, 2014Thermedical, Inc.Devices and methods for shaping therapy in fluid enhanced ablation
US8808287Dec 10, 2012Aug 19, 2014Covidien LpSuction coagulator
US20100205802 *Feb 18, 2009Aug 19, 2010Tyco Healthcare Group Lp.Two Piece Tube for Suction Coagulator
Legal Events
DateCodeEventDescription
May 15, 2013ASAssignment
Owner name: GYRUS ACMI, INC., MASSACHUSETTS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:BANK OF SCOTLAND;REEL/FRAME:030422/0113
Effective date: 20130419
Jul 5, 2012FPAYFee payment
Year of fee payment: 12
Jul 16, 2008FPAYFee payment
Year of fee payment: 8
Jun 23, 2004FPAYFee payment
Year of fee payment: 4
Dec 29, 2003ASAssignment
Owner name: THE GOVERNOR AND COMPANY OF THE BANK OF SCOTLAND,
Free format text: SECURITY INTEREST;ASSIGNOR:GYRUS ENT L.L.C.;REEL/FRAME:014805/0598
Effective date: 20030930
Owner name: THE GOVERNOR AND COMPANY OF THE BANK OF SCOTLAND 3
Free format text: SECURITY INTEREST;ASSIGNOR:GYRUS ENT L.L.C. /AR;REEL/FRAME:014805/0598
Aug 28, 2002ASAssignment
Owner name: GYRUS ENT L.L.C., TENNESSEE
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:SOMNUS MEDICAL TECHNOLOGIES, INC.;REEL/FRAME:013245/0290
Effective date: 20020718
Owner name: GYRUS ENT L.L.C. 2925 APPLING ROADBARTLETT, TENNES
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:SOMNUS MEDICAL TECHNOLOGIES, INC. /AR;REEL/FRAME:013245/0290
Sep 4, 1998ASAssignment
Owner name: SOMNUS MEDICAL TECHNOLOGIES, INC., CALIFORNIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:EDWARDS, STUART D.;LAX, RONALD G.;REEL/FRAME:009442/0968;SIGNING DATES FROM 19980813 TO 19980817